MAUDE Adverse Event Report: CARDINAL HEALTH 6308 2000 ML DRAIN BG W/SPOUT; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6308LL
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Codes	Tachycardia (2095); Abdominal Distention (2601)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that they had an issue with the silicone cap cover in a foley bag kit.A 71 y/o male was sent to the ed with a 3 way foley catheter in place.The patient presented with gross hematuria and a need for a blood transfusion following a urology office visit.Admission orders were placed including an order for bladder irrigation.The patient was transferred from the ed to 4 east at 10:00pm with the 3-way foley catheter in place.Upon arrival the floor rn observed a distended abdomen and the patient was complaining of pain.Continuous bladder irrigation (cbi) fluids were running but no active output was noted.Attempts were made to irrigate the foley to remove clots.The nurse noticed a cap on the catheter bag was inserted into the output port blocking output.The cap was removed and reported to her supervisors.The medicine provider ordered pain medication and ct abdomen/pelvis.At 12:51, results of the ct showed a possible bladder perforation.At 01:27, the patient developed tachycardia, low blood pressure and was admitted to the icu.At 6:00am, to or exploratory laparotomy/cystoscopy (note stated perforation of bladder due to over distention).Per additional information, the patient had 2 additional procedures after the bladder repair to manage his hematuria and abnormal bloodwork (low hemoglobin, platelets, etc.).The patient was discharged to hospice.
Additional Manufacturer Narrative
Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.A corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: 6308 2000 ML DRAIN BG W/SPOUT
• Common Device Name: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17483822
• Report Number: 9612030-2023-03782
• Device Sequence Number: 8885436
• Product Code: KNX
• UDI-Device Identifier: 10884521002708
• UDI-Public: 10884521002708
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 6308LL
• Device Catalogue Number: 6308LL
• Device Lot Number: 2303816164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown